• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS FORTEO 600 MCG/2.4 ML PEN INJ SYRINGES PISTON

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS FORTEO 600 MCG/2.4 ML PEN INJ SYRINGES PISTON Back to Search Results
Device Problem Defective Component (2292)
Patient Problems Bruise/Contusion (1754); Erythema (1840); Pain (1994)
Event Type  Injury  
Event Description
Pt states that in the last 2 shipment she has received, she says she received defective needles. She says dr had to add more pressure for needle to go in to dispense medication which caused it to be more painful and left area more red and caused a little bruising some days. She states some needles were ok and difference was that they went in smooth. No other info provided. Pt does not consent to be contacted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFORTEO 600 MCG/2.4 ML PEN INJ
Type of DeviceSYRINGES PISTON
Manufacturer (Section D)
ELI LILLY AND COMPANY, PHARMACEUTICAL DELIVERY SYSTEMS
MDR Report Key8655308
MDR Text Key146663861
Report NumberMW5087002
Device Sequence Number1
Product Code FMF
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 05/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

-
-